The Medicines (Medicines Act 1968 Amendment) Regulations 1977 No. 1050

Amendment of section 7 of the Act

2.—(1) Section 7 of the Act (product licences) shall be amended in accordance with this regulation.

(2) In subsection (5) for the words “is responsible for the composition of the product” there shall be substituted the words—

“(a) is responsible for the composition of the product, or

(b) in the case of a proprietory medicinal product, is responsible for the placing of that product on the market, in the United Kingdom.”.

(3) At the end of the section there shall be inserted the following subsection—

“(7) In this section—

(a) “proprietary medicinal product” means a ready-prepared medicinal product placed on the market in the United Kingdom under a special name and in a special pack,

(b) for the purposes of paragraph (a) “medicinal product” does not include—

(i) vaccines, toxins or serums,

(ii) medicinal products based on human blood or blood constituents or radioactive isotopes,

(iii) homoeopathic medicinal products, or

(iv) veterinary drugs.”.

(4) This regulation shall come into force on 1st September 1977.